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November 10, 2002
Reported Adverse Drug Events in Infants and Children Under 2 Years of Age
Moore TJ, Weiss SR, Kaplan S, Blaisdell CJ. Pediatrics. 2002 Nov;110(5):e53.
Commentary by Charles Cot�, M.D.
These authors have performed a valuable service by reviewing all adverse drug reports in the FDA MedWatch system for 3 years (1997-2000). The authors found that drug therapy in this age group was a significant factor in morbidity and mortality. However, the authors admit the limited value of the data in the system and the difficulty in assessing the true causal relationship, i.e., was this true-true and related or true-true and unrelated? Examples include the high mortality associated with nitric oxide! Obviously, this is unlikely to be a causal relationship because of the nature of the treatment populations. Of greater interest is the 20 cases related to sevoflurane. Again, we do not know if these adverse events were related to anesthetic overdose or simply that the child was being anesthetized with sevoflurane and there was an underlying cardiac or other surgical problem that led to the morbidity or mortality. Regardless, it is important to consider that drug development in children and drug research in children is essential if we are to improve our care and reduce adverse drug events. The very children who have the greatest patient-to-patient variability in drug response are those who have had the least benefit of drug research, i.e., neonates and toddlers. Therefore, I thought it would be helpful to review where the FDA started, pediatric influences in policy change, and where things stand in the ever-changing present. [see New Changes at the FDA and How this has Affected Drug Development for Children for further commentary]
ABSTRACT
Reported Adverse Drug Events in Infants and Children Under 2 Years of Age
AUTHORS:
Moore TJ, Weiss SR, Kaplan S, Blaisdell CJ.
SOURCE:
Pediatrics 2002 Nov;110(5):e53
OBJECTIVE: To characterize risks to infants and young children from drugs and biological products that were identified in spontaneous adverse event reports submitted to the US Food and Drug Administration.
METHODS: Of >500 000 MedWatch adverse event reports received by the Food and Drug Administration from November 1997 through December 2000, we identified 7111 reports about infants and children younger than age 2. The reports were analyzed for health outcome (eg, death, hospitalization, congenital anomaly), principal suspect drug, and whether the route of drug exposure was direct administration or
through the mother in the perinatal period.
RESULTS: Drug therapy was associated with an average of 243 reported deaths annually over the 38-month study period, with 100 (41%) occurring during the first month of life and 204 (84%) during the first year. In 1432 (24%) reported adverse event cases of all levels of severity, exposure to the drug was from the mother during pregnancy, delivery, or lactation. Although 1902 different drugs, biological products, and other chemicals were identified in the reports, only 17 drugs or biological products were a suspect in 54% of all serious and fatal adverse events in drugs administered directly.
CONCLUSION: Adverse reactions to drug therapy are a significant cause of death and injury in infants and children under 2 years of age. Drugs administered to the mother in the perinatal period constituted a major route of exposure to adverse drug advents. These results underscore the need for additional drug testing in the youngest pediatric patients and for carefully weighing the risks versus benefits of medication.
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